Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
Blokhin's Russian Cancer Research Center
142 participants
Jun 5, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study. Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
Eligibility
Inclusion Criteria6
- Signed informed consent
- Absence of distant metastases (M0)
- ECOG (Eastern Cooperative Oncology Group) status 0-2
- completed course of adjuvant treatment
- Absence of acute inflammatory parastomal complications
- Integrity of colorectal anastomosis
Exclusion Criteria6
- Inability to obtain consent to participate
- Synchronous and metachronous malignant neoplasms
- Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system
- Parastomal inflammation and other conditions that increase the risk of postoperative complications
- Pregnancy
- HIV infection
Interventions
We'll use mesh repair for prevention of stoma-site hernias in the study group.
We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05939687